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BattlefieldWoundDressing(XSTAT30)OkayedforCivilian
Use
RobertLowes |December07,2015
Anovelwounddressingnowusedtocontrolseverebleedingonthebattlefieldwillbeavailabletocivilianfirst
responderstreatingtraumapatients,theUSFoodandDrugAdministration(FDA)hasannounced.

TheagencytodayclearedXSTAT30(RevMedX)wounddressingforpatientsathighriskforimmediate,life
threatening,andseverehemorrhagicshockandnoncompressiblejunctionalwoundswhentheycan'tbetreatedat
anemergencycarefacilitywithinminutes.XSTAT30isnotindicatedforcertainpartsofthechest,abdomen,pelvis,
ortissueabovethecollarbone,accordingtoanFDAnewsrelease.

Thewounddressingproductconsistsofasyringestyleapplicatorholding92compressedcellulosespongeswithan
absorbentcoating.Thespongesexpandwithbloodandfluidtofillthewoundcavity,temporarilyblockingbloodflow
forupto4hours.Eachapplicator'sworthofspongescanabsorbaboutonepintofblood,althoughthenumberof
spongesneededtocontrolbleedingwillvarybythesizeanddepthofthewound.

TheFDAcitedresearchbytheUSArmyshowingthat30%to40%ofciviliandeathsfromtraumaticinjuryresultfrom
hemorrhaging,oftenbeforethepatientreachesthehospital.

TheFDAapprovedanearlierversionoftheproductXSTATformilitaryuseinApril2014.WillFox,vice
presidentofsalesandmarketingatRevMedX,saidhiscompanyhadalwaysenvisionedacivilianapplicationforthe
bloodabsorbingsponges.Peopleinjuredincarwrecks,industrialaccidents,andshootingshavethesamekindof
severewoundsseenonthebattlefield,FoxtoldMedscapeMedicalNews.

Theagencylimitedtheinitialproducttomilitaryuselastyeartogiveitatrialrunbeforeexpandingtheindication,he
said.

TheFDAclearedXSTAT30throughits510(k)reviewprocess,inwhichthemanufacturershowedthattheproduct
wassubstantiallyequivalenttoitsXSTATpredecessorintermsofsafetyandeffectiveness.

Moreinformationontoday'sFDAdecisionisavailableontheagency'swebsite.

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Citethisarticle:BattlefieldWoundDressing(XSTAT30)OkayedforCivilianUse.Medscape.Dec07,2015.

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